Condition category
Cancer
Date applied
01/07/2001
Date assigned
01/07/2001
Last edited
05/11/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.bc2001.bham.ac.uk/

Contact information

Type

Scientific

Primary contact

Ms Rebecca Lewis

ORCID ID

Contact details

Institute of Cancer Research Clinical Trials and Statistics Unit (ICR-CTSU)
Section of Epidemiology
Brookes Lawley Building
Cotswold Road
Sutton
Surrey
SM2 5NG
United Kingdom
+44 (0)20 8722 4081
Rebecca.Lewis@icr.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00024349

Protocol/serial number

BC2001

Study information

Scientific title

2x2 Factorial randomised phase III study comparing standard versus whole bladder volume radiotherapy with and without synchronous chemotherapy in muscle invasive bladder cancer

Acronym

Study hypothesis

Added 31/05/2011:
Study hypothesis: BC2001 is a multi-centred randomised controlled trial which aims:
a) To investigate the efficacy and toxicity of synchronous chemo-radiotherapy in conservative management of invasive bladder cancer compared to radiotherapy alone.
b) To investigate whether modifying the volume of bladder irradiated by the full dose of radiotherapy can reduce toxicity of radiotherapy in the conservative treatment of invasive bladder cancer, without impacting on local control.

Please note, as of 02/06/2011 updates have been made to this trial record. These can be found under this date in the relevant sections below.

Ethics approval

North West 5 Research Ethics Committee 05/03/2001 (ref: MREC 00/8/075)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Bladder (advanced)

Intervention

Four possible randomisations as follows:
1. Synchronous 5-Fluorouracil (5-FU) and Mitomycin with standard radiotherapy (to the whole bladder)
2. Synchronous 5-FU and Mitomycin with whole bladder volume radiotherapy
3. Standard radiotherapy to the whole bladder and no chemotherapy
4. Whole bladder volume radiotherapy and no chemotherapy

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Loco-regional (Ui.e. pelvic nodes & bladderU) disease free survival. The particular time point of interest is 2 years post randomisation. (Added 02/06/2011)

Secondary outcome measures

Secondary endpoint:
Disease free survival, Metastases free survival, Late toxicity at 1 and 2 years as assessed by RTOG and Lent Som toxicity scores, bladder capacity and Fact-BL QoL score. This endpoint is of particular importance in the radiotherapy comparison.

Tertiary endpoints:
1. Acute toxicity
2. Cystoscopic local control at 6 months, 1 year and 2 years post randomisation
3. Rate of salvage cystectomy
4. Overall survival

Overall trial start date

03/08/2001

Overall trial end date

31/08/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 or over
2. Histologically proven invasive bladder carcinoma (adenocarcinoma, transitional or squamous cell carcinoma)
3. Localised muscle invasive carcinoma either surgically or by imaging (T2-T4a, N0, M0)
4. Patients with multiple tumours at the time of randomisation are not eligible for the radiotherapy volume randomisation but may be randomised to whole bladder radiotherapy with or without chemotherapy
5. World Health Organisation (WHO) performance status 0-2 Leucocytes >4.0 x 10(9)/ l; Platelets >100 x 10(9)/l Glomerular filtration rate (GFR) >25 ml/min Serum bilirubin <1.5 upper limit of reference range (ULRR) alanine amino transferase (ALT) or aspartate amino transferase (AST) <1.5 x ULRR
6. Patient available for long term follow up and in the opinion of the investigator, able to receive radical radiotherapy
7. Patients written informed consent
8. Able to understand and complete the QoL questionnaire (patient can enter study without QoL but ALL are invited)

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

350 (Added 02/06/2011)

Participant exclusion criteria

1. Uncontrolled systemic disease which would preclude the patient from the study
2. Pregnancy
3. Other malignancy within the previous 2 years (other than adequately treated BCC of the skin or adequately treated in situ carcinoma of the cervix uteri)
4. Previous malignancy that is likely to interfere with protocol treatment
5. Inflammatory bowel disease
6. Previous pelvic radiotherapy
7. Bilateral hip replacements compromising accurate radiotherapy planning

Recruitment start date

03/08/2001

Recruitment end date

31/08/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute of Cancer Research Clinical Trials and Statistics Unit (ICR-CTSU)
Sutton, Surrey
SM2 5NG
United Kingdom

Sponsor information

Organisation

Individual Sponsor (UK)

Sponsor details

Prof Nick James
Queen Elizabeth Hospital
Clinical Trials Unit
Edgbaston
Birmingham
B15 2TH
United Kingdom
+44 (0)121 414 4097
N.D.James@bham.ac.uk

Sponsor type

Other

Website

http://www.cancer.org.uk

Funders

Funder type

Charity

Funder name

Cancer Research UK

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22512481
2. 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23958147

Publication citations

  1. Results

    James ND, Hussain SA, Hall E, Jenkins P, Tremlett J, Rawlings C, Crundwell M, Sizer B, Sreenivasan T, Hendron C, Lewis R, Waters R, Huddart RA, , Radiotherapy with or without chemotherapy in muscle-invasive bladder cancer., N. Engl. J. Med., 2012, 366, 16, 1477-1488, doi: 10.1056/NEJMoa1106106.

  2. Results

    Huddart RA, Hall E, Hussain SA, Jenkins P, Rawlings C, Tremlett J, Crundwell M, Adab FA, Sheehan D, Syndikus I, Hendron C, Lewis R, Waters R, James ND, Randomized noninferiority trial of reduced high-dose volume versus standard volume radiation therapy for muscle-invasive bladder cancer: results of the BC2001 trial (CRUK/01/004)., Int. J. Radiat. Oncol. Biol. Phys., 2013, 87, 2, 261-269, doi: 10.1016/j.ijrobp.2013.06.2044.

Additional files

Editorial Notes